Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a single-center, single-dose, open-label, Phase I study to evaluate the mass balance, biotransformation, pharmacokinetic characteristics, excretion pathways, and safety of a single oral 200 mg/5 µCi dose of \[14C\]Zorifertinib in healthy Chinese adult male participants. The study includes a screening period (Day -14 to Day -1) and a dosing and observation period (Day 1 to Day 14). Blood, urine, and feces samples will be collected to measure radioactivity, drug concentrations, and metabolites. Safety will be assessed by adverse events, vital signs, laboratory tests, 12-lead ECG, and ophthalmic examinations. The target total radioactivity recovery is ≥90% of the administered dose.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zdrowi mężczyźni pochodzenia chińskiego
- •Wiek od 18 do 45 lat
- •Prawidłowa masa ciała (BMI od 19 do 26, waga minimum 50 kg)
- •Pełne zrozumienie celu badania i dobrowolna zgoda na uczestnictwo
- •Zdolność do komunikacji z badaczami i stosowania się do instrukcji badania
✗ Disqualifies
- •Nieprawidłowe wyniki badań fizykalnych, pomiarów ciśnienia, analiz krwi lub moczu
- •Nieprawidłowe zapisanie czynności serca na elektrokardiogramie (EKG)
- •Dodatni wynik na wirusy zapalenia wątroby (HBV, HCV), syfilis lub HIV
- •Nieprawidłowe wyniki badania oczu
- •Stosowanie leków wpływających na metabolizm w ciągu 30 dni przed badaniem
- •Stosowanie leków na receptę, leków bez recepty lub suplementów diety w ciągu 14 dni przed badaniem
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Last updated (source)
- September 22, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, China
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/9/2026.
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